Frequently Asked Questions

Inflammatory bowel disease (IBD) involves
chronic inflammation of all or part of the digestive tract. IBD primarily
includes Ulcerative Colitis and Crohn’s disease. Both usually involve severe
diarrhea, pain, fatigue, and weight loss. IBD can be debilitating and sometimes
leads to life-threatening complications. Ulcerative colitis causes long-lasting
inflammation and sores (ulcers) in the innermost lining of your large intestine
(colon) and rectum. Crohn’s disease causes inflammation of the lining of your digestive
tract. In Crohn’s disease, inflammation often spreads deep into affected
tissues. The inflammation can involve different areas of the digestive tract.
Collagenous colitis and lymphocytic colitis also are considered inflammatory
bowel diseases but are usually regarded separately from classic inflammatory
bowel disease. (Source: Mayo Clinic Staff)

“ECM” stands for Extracellular Matrix, a
mature tissue engineering technology that Regentys is leveraging to the
gastrointestinal space. ECM is a meshwork of proteins and carbohydrates that
binds cells together or divides one tissue from another. (Source:
biologyreference.com) Many medical devices have been developed based on
this technology, and they have proven to be safe and effective for years. Regentys
is developing a novel approach to using ECM in the intestines to treat IBD.

ECMH (ExtraCellular Matrix Hydrogel) is a
liquid form of ECM. It consists of the Company’s unique porcine-derived,
engineered tissue material that will be delivered to the diseased colon where
it will build a protective barrier and act as a scaffold for natural tissue
recovery to occur. This mechanism has been demonstrated in multiple
applications in humans including esophageal and atrial septal defect repairs,
hernia grafts, pericardial closures, and burn and wound treatments; several of
these applications have been successfully marketed for more than a decade. ECMH
creates an environment favorable for the body to grow new tissue in place of
diseased or damaged tissue.

There is no cure for IBD. Current first-tier
drug treatment options include aminosalicylates (5-ASA) for mild cases to
systemic corticosteroids and potent immunosuppressants for moderate to severe
cases. Many advanced therapies subject the patient to potentially debilitating
side effects. Even so, approximately 20% to 30% of those afflicted with IBD
find no relief from any drug therapy. In such instances, patients undergo major
surgery to remove part of the intestines and or colon, a procedure that leads
to challenging, lifelong lifestyle changes.

We anticipate that our technology can be used
not just for IBD, but for other GI diseases such as rectal mucositis as well.
Rectal Mucositis can occur when cancer patients receive radiation and/or
chemotherapy in the pelvic region, leading to permanent damage to blood vessels
near the rectum. This often leads to uncontrolled bleeding and pain, and there
is no effective treatment for this condition.

Patients usually go through period of
remission (no disease activity) and flare (disease activity). While patients
are in remission, they usually have few or no symptoms. Still, there is
currently no cure for these diseases.

More than 5 million people suffer from the two
principle forms of IBD: Ulcerative Colitis (UC) and Crohn’s disease. In the
United States over 1.1 million people are afflicted with IBD. Regentys will
initially focus its resources to develop a treatment for Ulcerative Colitis
then leverage that experience to pursue Crohn’s disease. Approximately 700,000
Americans, and over 1 million Europeans, suffer from UC. According to studies
conducted earlier this decade, the annual per-patient per-year treatment costs
for UC ranged from $15,020 in the US to over $5,000 outside the US. Market data
obtained by Regentys indicated that 2012, revenues in the US and EU of
pharmacological agents to treat ulcerative colitis such as 5-ASA,
corticosteroids, 6MP (immunosuppressant), and biologics such as Remicade™ and
Humira™ totaled approximately $4.2 billion. That same report estimates an
annual 5% growth in this market; surpassing $6.8 billion by the year 2021.

Regentys is confident that its unique
engineered tissue material, ECMH, can be used to coat and protect the colon in
ulcerative colitis patients, allowing the body to heal the inflamed tissue. The
ECMH material would be delivered to the colon using a standard GI procedure,
creating a drug-free, surgery-free therapy to facilitate and maintain disease
remission.

The Company has obtained the exclusive license
from the University of Pittsburgh to develop new medical applications to treat
IBD. Regentys is collaborating with Stephen F. Badylak MD PhD DVM, Deputy
Director of The McGowan Institute for Regenerative Medicine at the University
of Pittsburgh, a world-class center for work in extracellular matrix (ECM).